MAUDE Adverse Event Report: MAKO SURGICAL CORP. BURR GUARD ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	204992
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
White inner sleeve partial came out post-op.Made loud noise during tibia wall.Case type: pka.
Additional Manufacturer Narrative
Reported event: it was reported that white inner sleeve partial came out post-op.Made loud noise during tibia wall.Product evaluation and results: the burr guard assembly did not show a missing "white sleeve" but the bearing was seized which could make the attachment louder.2049.Product history review: review of the product history records indicate 53 devices were manufactured under lot no 40m026640 and accepted into final stock on 01/05/2018.No non- conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 204992, lot number 40m026640 shows no additional complaints related to the failure in this investigation.Conclusions: the alleged failure mode was confirmed.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that there have been no nc¿s associated with the product and failure mode reported in this event.
Event or Problem Description
White inner sleeve partial came out post-op.Made loud noise during tibia wall.Case type: pka.

• Brand Name: BURR GUARD ASSEMBLY
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8858298
• Report Number: 3005985723-2019-00551
• Device Sequence Number: 2417880
• Product Code: OLO
• UDI-Device Identifier: 00848486021856
• UDI-Public: 00848486021856
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K142530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 204992
• Device Lot Number: 40M026640
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 08/03/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization